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ARCCの参加者におけるアベルマブ+アキシチニブの併用の有効性と安全性を評価するための観察研究（AVION）

2026年5月20日 更新者：Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

複数の EU 諸国における aRCC 患者におけるアベルマブ (BAVENCIO®) + アキシチニブ (INLYTA®) の有効性と安全性の実臨床評価 (AVION)

この研究の主な目的は、毎日の日常的な条件下での安全性と忍容性に加えて、進行性腎細胞癌（aRCC）の参加者の第一選択療法としてのアキシチニブと組み合わせたアベルマブ静脈内注入の有効性に関する知識を広げることです。臨床実践。

調査の概要

状態

完了

条件

研究の種類

観察的

入学 (実際)

105

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • ギリシャ
      • Athens、ギリシャ
        • Gen. Hos. "Alexandra"
      • Athens、ギリシャ
        • General Hospital of Athens G.Gennimatas
      • Athens、ギリシャ
        • Henry Dunant Hospital Center
      • Athens、ギリシャ
        • University Hospital of Athens Sotiria
      • Attiki、ギリシャ
        • Attikon Hospital
      • Chaïdári、ギリシャ
        • Attikon
      • Heraklion、ギリシャ
        • General Hospital "Venizelio"
      • Ioannina、ギリシャ
        • University Hospital of Ioannina
      • Kavala、ギリシャ
        • Kavala General Hospital
      • Larissa、ギリシャ
        • University Hospital of Larissa
      • Piraeus、ギリシャ
        • Metaxa Hospital
      • Piraeus、ギリシャ
        • Metropolitan Hospital Greece
      • Pátrai、ギリシャ
        • General Hospital of Patras "o Agios Andreas"
      • Thessaloniki、ギリシャ
        • Papageorgiou Hospital
      • Thessaloniki、ギリシャ
        • Agios Loukas Hospital
      • Thessaloniki、ギリシャ
        • Bioclinic (GRC)
      • Thessaloniki、ギリシャ
        • Saint Luke Hospital
  • ドイツ
      • Amberg、ドイツ
        • Klinikum St. Marien Amberg
      • Aschaffenburg、ドイツ
        • Klinikum Aschaffenburg Medizinische Klinik
      • Berlin、ドイツ
        • Zentrum für urologische Onkologie
      • Biberach an der Riss、ドイツ
        • Biberach
      • Bielefeld、ドイツ
        • Evangelisches Klinikum Bethel
      • Bielefeld、ドイツ
        • Evangelisches Krankenhaus Bielefeld
      • Braunschweig、ドイツ
        • Urologie im Schlosscarree
      • Deggendorf、ドイツ
        • Donauisar Klinikum Deggendorf
      • Dresden、ドイツ
        • Urologische Gemeinschaftspraxis
      • Eisenach、ドイツ
        • St. Georg Klinikum Eisenach gGmbH
      • Erlangen、ドイツ
        • Universitätsklinikum Erlangen
      • Essen、ドイツ
        • Universitaetsklinikum Essen Uroonkologie
      • Friedrichshafen、ドイツ
        • Klinikum Friedrichshafen GmbH daVinci® -Zentrum Bodensee
      • Fürth、ドイツ
        • Onkologische GP Dres. Wilke/Wagner/Petzoldt
      • Fürth、ドイツ
        • Onkologische SP Praxis Fürth
      • Goslar、ドイツ
        • MVZ Onkologische Kooperation Harz GbR
      • Halberstadt、ドイツ
        • Praxis Dr. Maas
      • Hamburg、ドイツ
        • Universitätsklinikum Hamburg-Eppendorf
      • Hanover、ドイツ
        • Medizinische Hochschule Hannover
      • Hanover、ドイツ
        • Vinzenzkrankenhaus Hannover
      • Heinsberg、ドイツ
        • Praxis Kretz
      • Jena、ドイツ
        • Universitätskinderklinik Jena
      • L.-Eisleben、ドイツ
        • Urologische Praxis Dr. Ralf Eckert
      • Luckenwalde、ドイツ
        • Urologische Praxis Dipl.-Med. Susanne Kloß
      • Lübeck、ドイツ
        • Universitatsklinik Schleswig-Holstein
      • Magdeburg、ドイツ
        • Schwerpunktpraxis für Hämatologie und Onkologie
      • Minden、ドイツ
        • Johannes Wesling Klinikum Minden der Mühlenkreiskliniken (AöR)
      • Münster、ドイツ
        • University of Munster
      • Münster、ドイツ
        • Uniklinikum Münster
      • Osnabrück、ドイツ
        • Marienhospital Osnabrück - Standort Natruper Holz
      • Osnabrück、ドイツ
        • Paracelsus Klinik Osnabrück
      • Osnabrück、ドイツ
        • Klinikum Osnabrück GmbH
      • Ostfildren、ドイツ
        • medius Klinik Ostfildern-Ruit
      • Rostock、ドイツ
        • Wissenschaftskontor Nord GmbH & Co. KG
      • Rüsselsheim am Main、ドイツ
        • GPR Klinikum Rüsselsheimg GmbH
      • Sigmaringen、ドイツ
        • SRH Kliniken Landkreis Sigmaringen (DEU)
      • Stolberg、ドイツ
        • Hämatologie und Onkologie Stolberg
      • Troisdorf、ドイツ
        • Praxis Troisdorf
      • Westerstede、ドイツ
        • Medizinische Studiengesellschaft Nord-West GmbH
      • Wetzlar、ドイツ
        • Lahn Dill Kliniken GmbH
  • ベルギー
      • Bonheiden、ベルギー
        • Imelda Ziekenhuis
      • Brasschaat、ベルギー
        • AZ Klina
      • Bruges、ベルギー
        • AZ Sint-Jan
  • ロシア
      • Irkutsk、ロシア
        • Regional Oncology Dispensary - Irkutsk

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

進行RCCの診断が確認された参加者は、この研究で観察されます。

説明

包含基準:

  • -Eastern Cooperative Oncology Group（ECOG）のパフォーマンスステータスが0、1、または2の参加者
  • -組織学的にRCCの診断が確認された参加者 組織学的起源
  • -局所進行/転移性疾患（つまり、[ie]、米国の癌に関する合同委員会ごとに新たに診断されたステージ4 RCC）または再発性疾患を有する参加者
  • -参加者は、承認された製品特性の要約（SmPC）に従って、第一選択療法としてアベルマブとアキシチニブの治療を1または2サイクル受けました
  • -この研究に参加するために書面によるインフォームドコンセントフォーム（ICF）に署名する意思のある参加者

除外基準:

  • -承認されたSmPCに従って、アベルマブまたはアキシチニブの禁忌のある参加者
  • -アベルマブとアキシチニブの開始前28日以内に薬物またはデバイスの介入臨床研究に参加した参加者

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
アベルマブ + アキシチニブ
この研究では、研究固有の介入はありません。 進行RCCの参加者 800ミリグラム（mg）のアベルマブを2週間ごとに静脈内投与し、5 mgのアキシチニブを1日2回経口投与する。この研究では24か月間。

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival Rate
時間枠：At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])
Overall survival rate was defined as the percentage of participants who are alive at 12 months after the index date. Percentage of participants alive at the time of outcome assessment (12 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival Rate
時間枠：At 24 months after index date (baseline visit as reported in the eCRF)
Overall survival rate was defined as the percentage of participants who are alive at 24 months after the index date. Percentage of participants alive at the time of outcome assessment (24 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
At 24 months after index date (baseline visit as reported in the eCRF)
Duration of Overall Survival
時間枠：From the index date (baseline visit as reported in the eCRF) to the date of death from any cause, (assessed up to 24 months after index date)
Duration of overall survival is defined as the time from index date to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) to the date of death from any cause, (assessed up to 24 months after index date)
Objective Response Rate (ORR) Assessed by Investigator up to 24 Months After the Index Date
時間枠：up to 24 months after the index date (baseline visit as reported in the eCRF)
Objective response rate was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) as best overall response up to 24 months after the index date. CR: Disappearance of all target and non-target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of their diameters, and no unequivocal progression of non-target lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
up to 24 months after the index date (baseline visit as reported in the eCRF)
Disease Control Rate (DCR) Assessed by Investigator up to 24 Months After the Index Date
時間枠：up to 24 months after the index date (baseline visit as reported in the eCRF)
Disease control rate is defined as the percentage of participants with objective response (complete response [CR] or partial response [PR] or stable disease [SD]) as best overall response up to 24 months after the index date. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
up to 24 months after the index date (baseline visit as reported in the eCRF)
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
時間枠：up to 24 months after the index date (baseline visit as reported in the eCRF)
DoR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
up to 24 months after the index date (baseline visit as reported in the eCRF)
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Assessed by Investigator
時間枠：From the index date (baseline visit as reported in the eCRF) to the date of disease progression or death from any cause, whichever occurred first (assessed up to 24 months after index date)
PFS time was defined as the time from index date to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered PD. The tumor response was determined according to RECIST version 1.1 and assessed by the investigator. PFS was calculated based on KM method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) to the date of disease progression or death from any cause, whichever occurred first (assessed up to 24 months after index date)
Progression-free Survival 2 (PFS2) According to RECIST Version 1.1 Assessed by Investigator
時間枠：From the index date (baseline visit as reported in the eCRF) to the date of disease progression on second-line treatment or death from any cause, whichever occurred first (assessed up to 24 months after index date)
PFS2 was defined as time interval from the index date to the date of disease progression on second-line treatment or death from any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The tumor response will be determined according to RECIST version 1.1 and assessed by the investigator. PFS2 was calculated based on Kaplan Meier method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) to the date of disease progression on second-line treatment or death from any cause, whichever occurred first (assessed up to 24 months after index date)
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score
時間枠：Index date (baseline visit as reported in the eCRF), at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 and 104 weeks
NCCN-FACT FKSI-19, a validated, disease-specific questionnaire for RCC. It includes 19 items across four domains, Disease-Related Symptoms-Physical (DRS-P), Disease-Related Symptoms-Emotional (DRS-E), Treatment Side Effects (TSE), and Functional Wellbeing (FWB), based on symptoms experienced over past 7 days. Responses were recorded on 5-point Likert scale (0 = not at all to 4 = very much), yielding a total score from 0 to 76, higher scores reflecting better quality of life. A negative mean change in score indicated worsening condition. Domain score ranges and directionality: DRS-P: 0-48, higher scores = fewer physical symptoms; DRS-E: 0-4, higher = fewer emotional symptoms; TSE: 0-12, higher = more severe side effects; FWB: 0-12, higher = better functional wellbeing. As per NCCN-FACT FKSI-19 scoring guidelines, the total Health-related quality of life (HRQoL) score (range 0-76) was calculated as sum of single items scores multiplied by 19 and divided by the number of items completed.
Index date (baseline visit as reported in the eCRF), at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 and 104 weeks
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs, TEAEs Leading to Permanent Treatment Discontinuation and TEAEs Leading to Death According to Medical Dictionary for Regulatory Activities (MedDRA)
時間枠：From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events with onset date or worsening during the on-treatment period. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs is defined as reasonably related to the study intervention. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
Number of Participants With Adverse Events Based on Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
時間枠：From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
Severity of TEAEs were evaluated using the NCI-CTCAE version 5.0. The grade are as follows: grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE. Number of participants with TEAEs grade greater than or equal to (>=) 3 were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
Time to Therapy Discontinuation Due to AE Greater Than or Equal to (>=) Grade-3
時間枠：From the index date (baseline visit as reported in the eCRF) up to 24 months
Time to therapy discontinuation due to AE >= grade 3 was reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) up to 24 months
Duration of Avelumab Plus Axitinib Therapy Among Participants Who Discontinued the Axitinib Due to All-Cause AEs >= Grade 3
時間枠：Time from first dose of study drug up to 24 months
The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. Duration of Avelumab plus Axitinib therapy (days) = (Date of discontinuation of Axitinib - Date of index date + 1). Duration of avelumab plus axitinib therapy among participants who discontinued the Axitinib due to all-cause AEs >= grade 3 was reported.
Time from first dose of study drug up to 24 months
Time to Onset of Treatment - Emergent Adverse Events (TEAEs)
時間枠：From index date (baseline visit as reported in the eCRF) up to 24 months
Time to onset of TEAE = Start date TEAE - Index date. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Duration of Treatment-Emergent Adverse Events (TEAEs)
時間枠：From index date (baseline visit as reported in the eCRF) up to 24 months
Duration of TEAE = (Stop date of TEAE - Start date of TEAE + 1) divided by 7. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Percentage of Participants With Therapy Modifications Due to Adverse Event Related to Avelumab Plus Axitinib Therapy
時間枠：From index date (baseline visit as reported in the eCRF) up to 24 months
Percentage of participants with therapy modifications due to AE related to avelumab plus axitinib therapy were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy
時間枠：From index date (baseline visit as reported in the eCRF) up to 24 months after the index date
Number of participants with different types of medical intervention or medications used for the management of TEAE related to avelumab plus axitinib therapy (e.g., use of corticosteroids, antihypertensive therapy, treatment for thyroid dysfunction, measures to decrease hemoglobin, and hematocrit) was reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months after the index date
Percentage of Participants Receiving Later-line Therapy
時間枠：From index date (baseline visit as reported in the eCRF) up to 24 months
Percentage of participants receiving later-line therapy were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Time to Second-line Therapy Initiation
時間枠：Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, assessed up to 24 months
Time to second line treatment was calculated as: (second line treatment start date - last dose of Avelumab plus Axitinib + 1)/30.4375.
Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, assessed up to 24 months
Number of Participants With Patient-reported Potential Signs and Symptoms of Immune-related AEs
時間枠：From index date (baseline visit as reported in the eCRF) up to 24 months
Number of participants with patient-reported potential signs and symptoms of immune-related AEs were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

協力者

Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany

捜査官

  • スタディディレクター：Medical Responsible、Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年8月9日

一次修了 (実際)

2024年8月8日

研究の完了 (実際)

2025年4月30日

試験登録日

最初に提出

2021年6月23日

QC基準を満たした最初の提出物

2021年6月23日

最初の投稿 (実際)

2021年6月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月16日

QC基準を満たした最後の更新が送信されました

2026年5月20日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • MS100070_0110

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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